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ManpowerGroup (NYSE:MAN) reported upbeat earnings for the first quarter on Thursday.

The company posted quarterly earnings of 51 cents per share which beat the analyst consensus estimate of 49 cents per share. The company reported quarterly sales of $4.510 billion which beat the analyst consensus estimate of $4.414 billion.

ManpowerGroup said it sees second-quarter GAAP EPS of 91 cents to $1.05, versus market estimates of 96 cents.

ManpowerGroup shares rose 1.5% to trade at $31.45 on Friday.

These analysts made changes to their price targets on ManpowerGroup following earnings announcement.

Baird analyst Mark Marcon maintained ManpowerGroup with an Outperform rating and lowered the price target from $50 to $45. Truist Securities analyst Tobey Sommer maintained the stock with a Hold and lowered the price target from $38 to $34. Considering buying MAN stock? Here’s what analysts think:

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ManpowerGroup maintains a hold rating as revenue recovery strengthens, but profitability remains under pressure, and consensus estimates appear optimistic. Q1 2026 saw credible topline improvement across France, Italy, Southern Europe, and the Manpower brand, with enterprise demand signaling early-stage recovery. Gross profit fell, gross margin missed guidance, and enterprise mix continues to weigh on margins despite cost-cutting and productivity initiatives.

On April 28, 2026, ManpowerGroup Inc (MAN) shares rose by 4.2%, currently trading at $31.22. The stock has experienced a 52-week range of $25.15 to $47.34, refl

CHICAGO--(BUSINESS WIRE)--Sikich, a professional services company specializing in consulting, technology and compliance today announced it has acquired Milwaukee-based Jefferson Wells and their 300+ employees in the U.S. from ManpowerGroup (NYSE: MAN). Jefferson Wells delivers solutions in risk & compliance, finance & accounting, and tax – across a diverse range of industries, including to public and highly regulated companies – through project consulting, integrated resourcing and executive search.

With over 30 years of operating history in the United States, Jefferson Wells brings a well-established reputation across key sectors including financial services, technology, and energy. This acquisition complements and strengthens Sikich's existing presence in healthcare, life sciences, and manufacturing and distribution. In 2025, Jefferson Wells generated U.S. revenues of $76 million. The transaction was valued at $100 million, with net cash proceeds at closing of approximately $89 million after working capital adjustments and other items.

“This acquisition enhances existing capabilities across our business, including deep expertise in risk and compliance, finance and accounting, and tax, making Jefferson Wells an ideal fit as we continue to scale,” said Sikich Chairman & Chief Executive Officer Christopher Geier. “Both teams share a conviction of a people first culture and the belief that clients deserve practical, actionable solutions delivered at the highest level of quality.”

“We are delighted to see Jefferson Wells U.S. join Sikich, where there is strong alignment in capabilities, culture, and growth ambition”, added Ger Doyle, North America region president, ManpowerGroup. “This creates exciting opportunities for the business and its people. My sincere thanks to the teams on both sides for their hard work and professionalism in bringing this together. As we move forward, we are energized to focus on our core business and continue delivering value for our clients and candidates across North America.”

The transaction closed on April 30.

About Sikich

Sikich offers the public and private sectors a diverse platform of professional services across consulting, technology and compliance. Highly specialized and hands-on teams deliver integrated solutions rooted in deep industry experience. Our approach is strategically and thoughtfully designed to help our clients, teams and communities accelerate success.

Sikich has approximately 2,000 team members and operates across North America, EMEA and APAC.

Sikich practices in an alternative practice structure in accordance with the AICPA Professional Code of Conduct and applicable law, regulations, and professional standards. Sikich CPA LLC is a licensed CPA firm that provides audit and attest services to its clients, and Sikich LLC and its subsidiaries provide tax and business advisory services to its clients. Sikich CPA LLC has a contractual arrangement with Sikich LLC under which Sikich LLC supports Sikich CPA LLC’s performance of its professional services. Sikich LLC and its subsidiaries are not licensed CPA firms.

“Sikich” is the brand name under which Sikich CPA LLC and Sikich LLC provide professional services. The entities under the Sikich brand are independently owned and are not liable for the services provided by any other entity providing services under the Sikich brand. The use of the terms “our company”, “we” and “us” and other similar terms denote the alternative practice structure of Sikich CPA LLC and Sikich LLC.

About ManpowerGroup

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, and Talent Solutions – creates substantially more value for candidates and clients across more than 70 countries and territories and has done so for more than 75 years. We are recognized consistently for our diversity – as a best place to work for Women, Inclusion, Equality, and Disability, and in 2026 ManpowerGroup was named one of the World's Most Ethical Companies for the 17th time – all confirming our position as the brand of choice for in-demand talent. For more information, visit www.manpowergroup.com.

As organizations struggle to turn AI investment into results, Experis advances its evolution as a global technology services leader built on the power of specialized talent and human expertise

, /PRNewswire/ -- Experis, part of the ManpowerGroup (NYSE: MAN) family of brands, today announced a global brand refresh built around a clear and differentiated market position: only Experis brings together specialized talent, technology services, and delivery expertise to help organizations turn innovation into measurable business outcomes.

New Experis logo Anchored in the idea that it takes Human Ingenuity to unlock the power of technology, the refreshed identity brings this positioning to life with a more confident, contemporary, and human-centered expression of the Experis brand. The core logo has been refined rather than reinvented, preserving brand equity while signaling a clear step forward. The evolution also reinforces Experis' new descriptor, A Global Leader in Technology Services, marking a deliberate shift from IT staffing provider to technology services leader.

The timing is deliberate. Organizations everywhere are investing heavily in AI and digital transformation, and the technology alone is not delivering the outcomes they need. What's missing is the human expertise to make it work.

"That gap is exactly where Experis lives," said Kye Mitchell, President, Experis U.S. "Every client we work with is trying to close the distance between the technology they've invested in and the outcomes they need. We close that gap, with the right talent, the right services, and the right expertise. That's 'Human Ingenuity' in practice."

"The technology market is moving faster than at any point in our history, and the organizations that win will be those that can marry technical infrastructure with human capability at a global scale," Experis Europe Brand Leader James Hallahan said. "That is exactly what Experis is built to do. This brand refresh gives us clarity, clearer language for what we do, a sharper position in a crowded market, and a brand that finally reflects the work we have been doing every day."

For clients, Human Ingenuity comes to life through Experis' enterprise AI services suite, which helps organizations move from AI experimentation to enterprise execution through specialized AI talent, governance-first delivery, and strategic technology partnerships. It is how Experis helps clients build and run AI solutions that produce real outcomes, not just pilots.

For technology professionals, Experis is introducing Say HI, the talent-facing expression of Human Ingenuity. Say HI is an invitation to bring skills, judgment, and ambition to organizations and challenges where they can make the greatest impact. It positions Experis as a career partner, not a transaction.

The refreshed brand launches globally today across Experis' digital and social channels. Rollout continues across all regional touchpoints throughout 2026.

ABOUT EXPERIS  

Experis®, a global leader in technology services, provides the experience and expertise to shorten the distance between innovation and business impact in a digital world. Experis is guided by the principle that only Human Ingenuity can unlock the true potential of advanced technologies like AI. For clients, Experis offers the right mix of talent and technology to accelerate progress and deliver real-world results. For individuals, Experis has the insight, size, and scale to help tech professionals expand their skills, increase their value, and find the right opportunities. By matching talent to technology in transformative ways, Experis creates brighter futures for everyone. Experis is part of the ManpowerGroup® (NYSE: MAN) family of brands, which also includes Manpower and Talent Solutions. 

For more information, visit www.experis.com, or follow us on LinkedIn. 

ABOUT MANPOWERGROUP

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, and Talent Solutions – creates substantially more value for candidates and clients across more than 70 countries and territories and has done so for more than 75 years. We are recognized consistently as a best place to work for Women, Inclusion, Equality, and Disability, and in 2026 ManpowerGroup was named one of the World's Most Ethical Companies for the 17th time; all confirming our position as the brand of choice for in-demand talent.

For more information, visit www.manpowergroup.com, or follow us on LinkedIn, Facebook, and Bluesky.

SOURCE ManpowerGroup

This milestone marks the 10th consecutive year of recognition on Forbes' staffing and recruiting rankings.

, /PRNewswire/ -- Manpower, a global leader in contingent staffing and part of the ManpowerGroup® (NYSE: MAN) family of brands, has been named the No. 1 Temporary Staffing Firm in the nation on Forbes' 2026 list of America's Best Temporary Staffing Firms. The independent ranking, developed in partnership with Statista, also placed Manpower among the nation's top five professional recruiting firms, marking the company's tenth consecutive year of recognition on Forbes' staffing and recruiting rankings.

Forbes Best Temporary Staffing Firms 2026 "This distinction is especially meaningful because it reflects the voices that matter most — our clients, candidates and peers," said Raj Namboothiry, Senior Vice President and Head of Manpower U.S. "Today, successful hiring requires a deep understanding of what motivates people and where they can thrive. Our teams bring that understanding to every client and candidate interaction."

Manpower's reach spans more than 70 countries, connecting hundreds of thousands of organizations with skilled talent and helping millions of people find meaningful work each year. In the U.S., the brand combines data-driven recruiting with its PowerSuite® assessment platform and MyPath® skilling program to help both employers and job seekers navigate a labor market reshaped by technology and shifting demand.

The 2026 rankings draw on feedback from approximately 13,800 recruiters, HR leaders, hiring managers and job candidates, generating more than 18,000 recommendations. Firms are ranked by the volume of recommendations received from peers, clients and candidates. Companies do not pay to participate or be selected. The full rankings are available at forbes.com.

For more information about Manpower and its staffing solutions, visit manpower.com.

ABOUT MANPOWER
Manpower® is a global leader in contingent staffing and permanent resourcing, providing companies with strategic and operational flexibility and creating talent at scale. Our talent agents and specialized recruiters leverage data-driven insights to assess, guide and place people into meaningful, sustainable employment, and our PowerSuite® tech platform enables assessment and matching to predict performance potential. Our Manpower MyPath® skilling program provides rapid skills development at scale with on-the-job training, market-based certifications, and coaching for roles in growth sectors. In this constantly shifting world, our flexible workforce solutions provide companies with the business agility needed to succeed. Manpower is part of the ManpowerGroup® (NYSE: MAN) family of brands, which also includes Experis and Talent Solutions.

For more information about Manpower, visit www.manpower.com or follow us on LinkedIn.

ABOUT MANPOWERGROUP
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower,  Experis, and Talent Solutions – creates substantially more value for candidates and clients across more than 70 countries and territories and has done so for more than 75 years. We are recognized consistently as a best place to work for Women, Inclusion, Equality, and Disability, and in 2026 ManpowerGroup was named one of the World's Most Ethical Companies for the 17th time; all confirming our position as the brand of choice for in-demand talent.

For more information, visit www.manpowergroup.com, or follow us on LinkedIn, Facebook, and Bluesky.

SOURCE ManpowerGroup

New Experis research reveals CIOs' top priorities have shifted dramatically in just one year, as AI transforms what leadership requires.

, /PRNewswire/ -- One year ago, cybersecurity kept CIOs up at night. Today, business-IT alignment has overtaken cybersecurity as the top CIO priority for the first time, as technology leaders face rising pressure to prove the business value of AI investments. According to the CIO 2026 Outlook report released today by Experis, a global leader in technology services and part of the ManpowerGroup® (NYSE: MAN) family of brands, CIOs are under greater pressure than ever to translate technology potential into measurable business results, even as their peers struggle to grasp what that requires.

CIOs share the tech skills that matter most The report draws on responses from 1,930 technology leaders across 12 countries, expanding significantly from the 1,400 respondents across nine countries surveyed in 2025. The broader sample reflects growing global urgency around the CIO function as AI moves from proof of concept to proof of value.

"CIOs are being asked to lead AI transformation, drive growth, improve productivity, and manage risk all while facing significant talent shortages," said Kye Mitchell, President of Experis U.S. "When 61% of technology leaders say their C-suite peers don't fully understand the CIO role, it creates a barrier to execution. The organizations that will win with AI are the ones that treat technology leadership as a business leadership function and invest accordingly."

Key Findings:

Business-IT alignment surges to the top CIO priority: Nearly half (48%) of IT leaders say aligning IT strategy with business objectives is the most important thing a CIO can do, up sharply from 34% in 2025 — overtaking cybersecurity for the first time. Keeping pace with change is now the #1 business barrier: 44% of tech leaders cite the pace of technological innovation as their top challenge, up from 34% in 2025. The pressure is most acute in Israel (63%), Sweden (57%), and Switzerland (56%). AI is generating returns, but scrutiny is rising: 54% of tech leaders say AI investments are already producing positive ROI. Still, 31% believe their organizations are overinvesting in AI, and just 17% classify delivering AI solutions as a top CIO responsibility. CIOs remain misunderstood: 61% of tech leaders say their senior leader peers do not fully understand the CIO role and its responsibilities, up from 49% in 2025. Training and risk strategies are slipping: Just 72% of IT leaders say their risk strategy aligns with their cybersecurity readiness, down from 77% in 2025. Only 72% conduct regular cybersecurity training, a slight decline from 74% last year. Digital sovereignty concerns grow despite offshore expansion: 81% of IT leaders name digital sovereignty a high priority, yet 67% plan to increase their dependence on offshore or nearshore IT delivery in 2026. Cybersecurity skills remain most in demand: 46% of tech leaders identify cybersecurity as the most important skill their IT teams need, followed by AI and machine learning (37%) and cloud computing (31%). Talent acquisition and retention persist as a top challenge: CIOs continue to struggle to find workers with rapidly evolving tech skills, with traditional hiring approaches falling short of the pace of change. "One of the most striking findings in this year's data is the gap between stated priorities and actual behavior on sovereignty," James Hallahan, Experis Europe Brand Leader, said. "Eighty-one percent of tech leaders say digital sovereignty is a high priority, yet two-thirds are planning to increase their dependence on offshore delivery. In Europe, where regulatory exposure and geopolitical risk make data residency a board-level conversation, that disconnect has real stakes. Organizations need to decide what sovereignty actually means to them operationally, not just rhetorically, before the gap between their stated priorities and their actual investments becomes a liability."

Six in ten tech leaders are actively implementing AI-based technologies into current systems. One-third (34%) report that automation and AI-powered solutions are delivering the best ROI in production, while 41% still see cloud computing and scalable digital infrastructure as the top ROI drivers. Cybersecurity and digital sovereignty top the list of priorities earmarked for budget increases in 2026 even as the share of IT leaders whose risk strategy aligns with their cybersecurity readiness has declined, from 77% in 2025 to 72% today.

For the full report and insights, visit www.experis.com/cio-outlook.

ABOUT EXPERIS
Experis®, a global leader in technology services, provides the experience and expertise to shorten the distance between innovation and business impact in a digital world. Experis is guided by the principle that only human ingenuity can unlock the true potential of advanced technologies like AI. For clients, Experis offers the right mix of talent and technology to accelerate progress and deliver real-world results. For individuals, Experis has the insight, size, and scale to help tech professionals expand their skills, increase their value, and find the right opportunities. By matching talent to technology in transformative ways, Experis creates brighter futures for everyone. Experis is part of the ManpowerGroup® (NYSE: MAN) family of brands, which also includes Manpower and Talent Solutions. 

For more information, visit www.experis.com, or follow us on LinkedIn. 

SOURCE ManpowerGroup

NOVATO, Calif., April 29, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, today announced that it will host a conference call at 5:00 p.m.

First quarter total revenue of $136 million, Crysvita® revenue of $93 million and Dojolvi® revenue of $18 million

For the quarter ended March 2026, Ultragenyx (RARE - Free Report) reported revenue of $136 million, down 2.4% over the same period last year. EPS came in at -$1.84, compared to -$1.57 in the year-ago quarter.

The reported revenue represents a surprise of -15.66% over the Zacks Consensus Estimate of $161.26 million. With the consensus EPS estimate being -$1.55, the EPS surprise was -18.96%.

While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health.

Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance.

Here is how Ultragenyx performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:

Revenues- Dojolvi: $18 million compared to the $20.67 million average estimate based on six analysts. The reported number represents a change of +5.8% year over year.Revenues- Evkeeza: $18 million versus $16.22 million estimated by six analysts on average. Compared to the year-ago quarter, this number represents a +63.2% change.Revenues- Mepsevii: $7 million versus the six-analyst average estimate of $9.37 million. The reported number represents a year-over-year change of -16.5%.Revenues- Total Crysvita Revenue: $93 million compared to the $114.17 million average estimate based on five analysts.Revenues- Product sales: $89 million versus $94.98 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a -2.7% change.Revenues- Royalty revenue: $47 million versus the four-analyst average estimate of $62.78 million.View all Key Company Metrics for Ultragenyx here>>>

Shares of Ultragenyx have returned +8.5% over the past month versus the Zacks S&P 500 composite's +9.5% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term.

Key Takeaways Ultragenyx Q1 revenues fell 2% as Crysvita sales declined due to seasonal and ordering effects.RARE saw Evkeeza sales jump 64% on new country launches and early access demand.Ultragenyx expects FDA decisions on UX111 and DTX401 later in 2026 amid other pipeline progress. Ultragenyx Pharmaceutical (RARE - Free Report) reported first-quarter 2026 loss of $1.84 per share, wider than the Zacks Consensus Estimate of a loss of $1.55. The company had incurred a loss of $1.57 per share in the year-ago quarter.

Ultragenyx’s total revenues amounted to $136 million in the reported quarter, which declined 2% year over year due to lower product sales. The top line missed the Zacks Consensus Estimate of $161 million.

The company markets four drugs, namely Crysvita, Mepsevii, Dojolvi and Evkeeza. Crysvita is approved for treating X-linked hypophosphatemia, an inherited disorder and tumor-induced osteomalacia, an ultra-rare disease. Mepsevii is approved to treat Mucopolysaccharidosis VII, also known as Sly syndrome. Dojolvi is approved for treating all forms of long-chain fatty acid oxidation disorders. Evkeeza is indicated for homozygous familial hypercholesterolemia (HoFH).

In 2022, Ultragenyx announced a license and collaboration agreement with Regeneron Pharmaceuticals (REGN - Free Report) for Evkeeza, which is approved in multiple geographies as a first-in-class therapy for use together with diet and other low-density lipoprotein-cholesterol-lowering therapies to treat adults and adolescents aged 12 years and older with HoFH. Per the deal, RARE has obtained the rights to develop, commercialize and distribute Evkeeza outside the United States. The regions include the European Economic Area. The collaboration with Regeneron for Evkeeza gives Ultragenyx a fourth approved product that adds to the top line. However, REGN solely commercializes Evkeeza in the United States.

RARE’s Q1 Results in DetailCrysvita’s total revenues were $93 million, down 10% year over year, due to expected seasonality in the U.S. and Canada and ordering patterns in Brazil. Crysvita’s net product revenues in the first quarter of 2026 included $39 million from North America, $46 million from Latin America and Turkey, and $8 million from Europe.

Mepsevii product revenues decreased 13% year over year to $7 million in the reported quarter. Dojolvi product revenues were $18 million, up 6%, driven by new patient demand. Evkeeza recorded sales of $18 million in the first quarter, up 64%, driven by increased demand from new country launches and early access.

Year to date, shares of Ultragenyx have gained 8.7% against the industry’s 2.4% decline.

Image Source: Zacks Investment Research

Operating expenses of $305 million in the quarter rose 8% year over year due to increased investments in multiple late-stage pipeline programs and marketing costs for approved drugs. Operating expenses included research and development (R&D) expenses of $187 million (up 13%), selling, general and administrative (SG&A) expenses of $88 million (up 1%) and cost of sales of $30 million (up 3%).

Cash, cash equivalents and marketable securities amounted to $534 million as of March 31, 2026, compared with $737 million as of Dec. 31, 2025.

RARE Reiterates 2026 Financial GuidanceUltragenyx continues to expect total revenues in 2026, excluding potential revenues from new product launches, between $730 million and $760 million, which suggests growth of approximately 8-13% compared to 2025.

Crysvita revenues in 2026 are expected to be in the range of $500-$520 million, indicating growing underlying global demand partially offset by the expected timing of ordering patterns in Brazil. On the other hand, Dojolvi revenues are expected to be between $100 million and $110 million in 2026.

RARE’s Key Pipeline UpdatesIn April 2026, the FDA accepted the resubmitted biologics license application (BLA) seeking accelerated approval of UX111 for the treatment of MPS IIIA. The application included extensive long-term data with follow-up of up to eight years. The data showed sustained clinical benefits compared with the decline seen in natural history studies, along with durable treatment effects across multiple clinical measures and biomarkers, while maintaining an acceptable safety profile. A final decision from the regulatory body is expected on Sept. 19, 2026.

Ultragenyx’s GTX-102, an investigational antisense oligonucleotide, is being developed in the pivotal phase III Aspire study for treating Angelman syndrome (AS) patients with a genetically confirmed diagnosis of UBE3A deletion. Top-line data is expected in the second half of 2026. Enrollment in the phase II/III Aurora study is currently ongoing to evaluate the safety and efficacy of GTX-102 for treating other AS genotypes in other patient age groups, with the first patient dosed in October 2025. This additional study aims to enable treatment for a broader range of AS patients.

The FDA has also accepted for review Ultragenyx’s BLA for its investigational AAV8 gene therapy, DTX401, to treat glycogen storage disease type Ia. A final decision from the FDA is expected on Aug. 23, 2026. The regulatory body also recently informed RARE that an Advisory Committee meeting is not anticipated at this time. Ultragenyx is also evaluating UX701, an investigational AAV9 gene therapy, in a phase I/II/III Cyprus2+ study to treat Wilson disease and expects to share top-line data later in 2026.

RARE’s Zacks Rank & Stocks to ConsiderUltragenyx currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) and Inovio Pharmaceuticals (INO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have declined from $2.82 to $2.79. CPRX shares have gained 32.3% year to date.

Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.

Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.06. INO shares have plunged 34.5% year to date.

Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.

May 06, 2026 16:30 ET  | Source: Ultragenyx Pharmaceutical Inc.

NOVATO, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, today announced that Howard Horn, the company's Chief Financial Officer and Executive Vice President and Joshua Higa, Chief of Staff and Vice President of investor relations, will participate in a fireside at Bank of America’s 2026 Healthcare Conference on Tuesday, May 12, 2026, at 2:20 PM PT.

The live and archived webcast of the panel will be accessible from the company’s website at https://ir.ultragenyx.com/events-presentations.

About Ultragenyx Pharmaceutical Inc.

Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the company's website at: www.ultragenyx.com.

Contacts Ultragenyx Pharmaceutical, Inc.
Investors
Joshua Higa
[email protected]

Ultragenyx Pharmaceutical Inc. (RARE) Presents at Bank of America Global Healthcare Conference 2026 Transcript

New York, New York--(Newsfile Corp. - June 1, 2026) - Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) breached their fiduciary duties to shareholders.

According to a federal securities lawsuit, Insiders at Ultragenyx Pharmaceutical caused the company to misrepresent or fail to disclose the true state of setrusumab's potential and the risk inherent in the study protocols put forth; notably, that, while setrusumab does increase material bone density, this increase does not correlate to a decrease in annualized fracture rates.

If you currently own RARE and purchased prior to August 03, 2023 please contact Justin Kuehn, Esq. by email at [email protected] or call (833) 672-0814. Kuehn Law pays all case costs and does not charge its investor clients. Shareholders should contact the firm immediately as there may be limited time to enforce your rights.

Why Your Participation Matters:

As a shareholder your voice matters, and by getting involved, you contribute to the integrity and fairness of the financial markets. Your investment. Your voice. Your future.™

For additional information, please visit Shareholder Derivative Litigation - Kuehn Law.

Attorney advertising. Prior results do not guarantee similar outcomes.

Contacts:
Kuehn Law, PLLC
Justin Kuehn, Esq.
53 Hill Street, Suite 605
Southampton, NY 11968
[email protected]
(833) 672-0814

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/299740

Source: Kuehn Law, PLLC

New Phase 3 MITIGATE Open-Label Extension Data Support the Long-Term Safety Profile and Sustained Results of UPLIZNA® in IgG4-RD

Real-World Evidence Supports TAVNEOS® Efficacy and Safety Profile with Reduced Steroid Use in ANCA-Associated Vasculitis

, /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data across rare autoimmune and inflammatory diseases at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, taking place from June 3-6 in London.

New data from the Phase 3 MITIGATE trial of UPLIZNA® (inebilizumab) provide insights into the biology of immunoglobulin G4-related disease (IgG4-RD),1 while additional analyses support its long-term safety profile and sustained results in IgG4-RD.2 Additionally, new real-world evidence on TAVNEOS® (avacopan) further support its established efficacy and safety profile with reduced steroid use in people living with anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.3

"Patients living with rare autoimmune diseases still face significant unmet medical needs despite advances in treatment, with conditions often being difficult to diagnose and challenging to manage," said Paul Burton, M.D., Ph.D., chief medical officer at Amgen. "The data we're presenting at EULAR deepen our understanding of disease biology and demonstrate the strength of our portfolio of options for patients with these conditions, reflecting our commitment to advancing the science and delivering meaningful progress for patients."

Key presentations include:

Long-term Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Primary Results from Year 1 of the Open-Label Period (OLP) of the Phase 3 MITIGATE Trial
Abstract #POS0440, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST

IgG4-RD is a chronic and debilitating condition, marked by recurrent, unpredictable flares that can potentially impact multiple organs.4,5 New Phase 3 MITIGATE data further support the longer-term clinical profile of UPLIZNA.

Key findings include:

In the first year of the OLP, these data demonstrated sustained results and disease control with continued UPLIZNA treatment in patients with IgG4-RD. No patients (0%) who received UPLIZNA in the randomized controlled period (RCP) and continued with UPLIZNA in the OLP (N=56) experienced a flare, and 71.4% achieved flare-free, glucocorticoid-free complete remission at year 1 of the OLP.2 5.9% of patients who received placebo in the RCP and transitioned to UPLIZNA in the OLP (N=51) experienced a flare, and 41.2% achieved flare-free, glucocorticoid-free complete remission at year 1 of the OLP.2 Safety results were consistent with the established safety profile of UPLIZNA. The most common adverse events in the OLP were COVID-19, upper respiratory tract infection, cough and influenza.2 Across the combined RCP and OLP period, median total UPLIZNA treatment exposure was 2.2 years among participants who received ≥1 dose of inebilizumab.2 "For clinicians, a sustained reduction in flares and timely intervention are central to improving long-term outcomes," said John Stone, M.D., M.P.H., principal investigator and a professor of medicine at Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital. "The new MITIGATE data reinforce the long-term safety and efficacy profile of UPLIZNA while advancing our understanding of how IgG4-RD progresses over time. These findings may help clinicians identify opportunities for earlier intervention and reduce avoidable flares."

Natural History of IgG4-RD: Patterns of Organ Involvement and Flare-associated Biomarker Changes in the Phase 3 MITIGATE Trial
Abstract #OP052, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 4:30–4:40 p.m. BST

The first-of-its-kind natural history analysis reinforced the chronic and unpredictable nature of IgG4-RD, underscoring widespread and diverse multi-organ involvement and the need for earlier intervention and more comprehensive monitoring and risk stratification.

Key findings include:

Dynamic patterns of organ involvement over time, including the emergence of new organ manifestations and biological signals that may precede disease flares.1 CD19+ B cells were the first biomarker to rise ahead of a flare, followed by increases in total IgG and IgG subsets within the 30-day window preceding a flare.1 An additional exploratory combined analysis (Abstract #POS0089) of clinical trial RCP and OLP data in MITIGATE (N=119) showed how long-term use of UPLIZNA resulted in mostly mild immunoglobulin (Ig) reduction, with no significant association between these Ig reductions and occurrence of infections or serious infections. The incidence of infections and serious infections did not increase with each additional year of UPLIZNA treatment.

Real-World Evidence Supports TAVNEOS Efficacy, Safety and Reduced Steroid Use

The AQUARIUS analyses (Abstracts #POS01356 and #POS08673), conducted at Massachusetts General Hospital and Northwestern University, evaluated the largest U.S. real-world cohort to date of patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) treated with TAVNEOS (n=159). The findings provide new insights into clinical outcomes in patients with ANCA-associated vasculitis and are consistent with the established clinical efficacy and safety profile of TAVNEOS in patients with severe active GPA or MPA.3,6

"Real-world experience with TAVNEOS across two large healthcare systems demonstrates that many patients can achieve meaningful disease control with reduced reliance on glucocorticoids when considering prior standard-of-care glucocorticoid regimens," said Naomi Patel, M.D., rheumatologist at Massachusetts General Hospital and study investigator. "Because prolonged steroid use carries significant risks for patients, these findings are encouraging and also suggest that shorter steroid tapers (e.g., < 2 months) may reduce overall glucocorticoid exposure without compromising effectiveness outcomes."

Key findings include:

Results highlighted variability in glucocorticoids (GCs) tapering strategies in real world practice and showed that many patients were able to taper to very low or no doses of GCs quickly.3 Observations underscored the complexity of managing ANCA-associated vasculitis and pointed to opportunities to further optimize treatment approaches to reduce steroid exposure while maintaining disease control.3,6 The safety profile observed in this real-world setting was consistent with the established safety profile in patients with severe active GPA or MPA.3,6 Among patients who experienced hepatic adverse events, all hepatic abnormalities were resolved. "People living with ANCA-associated vasculitis often have limited treatment options and may rely heavily on steroids for disease control," said Joyce Kullman, executive director, Vasculitis Foundation. "Given the challenges associated with long-term steroid use, these new data reinforce that TAVNEOS can help patients achieve disease control with reduced steroid use. For the vasculitis community, this may represent a step toward reducing treatment burden over time."

For more information on the full list of Amgen abstracts and presentation times, see below.

All Amgen-sponsored abstracts being presented at EULAR:

UPLIZNA® (inebilizumab)

Long-term Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Primary Results from Year 1 of the Open-Label Period of the Phase 3 MITIGATE Trial
Abstract #POS0440, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST Immunogenicity and Impact of Anti-drug Antibodies on the Efficacy and Pharmacokinetics of Inebilizumab In MITIGATE, a Phase 3 Trial in IgG4-Related Disease
Abstract #POS0432, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST Atypical IgG4-Related Disease: Re-Examining the Entry Criteria of the 2019 ACR/EULAR Classification Criteria
Abstract #POS0439, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST Natural History of IgG4-RD: Patterns of Organ Involvement and Flare-associated Biomarker Changes in the MITIGATE Trial
Abstract #OP052, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 4:30–4:40 p.m. BST Serum IgG4 Elevation in IgG4-Related Disease: A Marker of Disease Phenotype and Organ Involvement
Abstract #OP056, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 5:10–5:20 p.m. BST Long-term Inebilizumab Treatment Results in Mild Immunoglobulin Reduction but No Increase in Infection Risk
Abstract #POS0089, Basic and Clinical Poster Tours: From Treatment to Outcome in Other Diseases (Poster Tour Presentation), Thursday, June 4 from 9:30–9:36 a.m. BST TAVNEOS (avacopan)

Reliability and Content Validity of a Definition of Severe Active Granulomatosis with Polyangiitis and Microscopic Polyangiitis
Abstract #POS0627, Poster View I (Poster View Presentation), Wednesday, 3 June at 4:20 p.m. BST Clinical Outcomes by Glucocorticoid Duration in Individuals with Granulomatosis with Polyangiitis and Microscopic Polyangiitis Treated with Avacopan in a Real-World Setting in Two Large Healthcare Systems
Abstract #POS0867, Poster View IV (Poster View Presentation), Thursday, 4 June at 4:00 p.m. BST One Year Real-World Effectiveness and Safety with Avacopan in Granulomatosis with Polyangiitis and Microscopic Polyangiitis in Two Large Healthcare Systems
Abstract #POS0135, Clinical Poster Tours: New frontiers in Small Vessel Vasculitis and Behcet's (Poster View Presentation), Thursday, 4 June from 1:36-1:42 p.m. BST KRYSTEXXA (pegloticase)

Association of Pegloticase-Induced Remission with Patient-Reported Quality of Life Outcomes in the MIRROR Randomized Controlled Trial
Abstract #POS0841, Poster View IV (Poster View Presentation), Wednesday, June 3 at 3:30 p.m. BST Reduction of Gout Flares with Pegloticase in Patients with or without Tophi at Baseline: A Post Hoc Analysis of the MIRROR Trial
Abstract #POS0421, Poster View I (Poster View Presentation), Thursday, June 4 at 4:00 p.m. BST Differences in Gout Management and Outcomes in Patients Referred From Primary Care to Rheumatology
Abstract #POS0843, Poster View IV (Poster View Presentation), Thursday, June 4 at 4:00 p.m. BST Baseline Predictors of Gout Remission During Intensive Urate-Lowering with Pegloticase: Post Hoc Analysis of the MIRROR Randomized Trial
Abstract #POS0169, Basic and Clinical Poster Tours: Advances in Gout and Crystal Disease (Poster Tour Presentation), Thursday, June 4 from 4:48–4:54 p.m. BST A Phase 4, Randomized, Double-blind Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous Pegloticase Administered Every 4 Weeks vs Every 2 Weeks with Weekly Methotrexate
Abstract #OP0294, Basic and Clinical Abstract Session: Beyond Hyperuricemia - New Insights into Gout Detection (Oral Abstract Presentation), Friday, June 5 from 9:05–9:15 a.m. BST OTEZLA (apremilast)

Efficacy of Apremilast in Early Oligoarticular Psoriatic Arthritis by Baseline Active Joint Count: A Post Hoc Analysis of the FOREMOST Study
Abstract #POS0490, Poster View I (Poster View Presentation), Wednesday, 3 June from 3:30-4:50 p.m. BST Partner-Led Abstracts

The Sjögren's Tool for Assessing Response (STAR) Demonstrates its Ability to Accurately Detect Treatment Efficacy in 15 Recent RCTs in Sjögren's Disease
Abstract #OP0125, Clinical Abstract Sessions: Positive Clinical Trials - A New Era in Sjögren's Disease (Oral Abstract Presentation), Wednesday, 3 June from 4:40-4:50 p.m. BST About UPLIZNA® (inebilizumab)
UPLIZNA is a humanized monoclonal antibody (mAb) that causes targeted and sustained depletion of key cells that contribute to underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). The precise mechanism by which UPLIZNA exerts its therapeutic effects in IgG4-RD is unknown. After two initial infusions, patients need one dose of UPLIZNA every six months.7

About TAVNEOS® (avacopan)
TAVNEOS is an orally administered small molecule indicated as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis (GPA/MPA). It is a selective complement 5a receptor (C5aR) antagonist that targets inflammation by blocking the activity of C5a, a key driver of neutrophil activation. By inhibiting C5aR, TAVNEOS helps reduce inflammation while preserving other complement system functions. The precise mechanism by which TAVNEOS exerts its therapeutic effects in ANCA-associated vasculitis has not been fully established.8

UPLIZNA® (inebilizumab-cdon) U.S. INDICATIONS
UPLIZNA® (inebilizumab-cdon) is indicated in adult patients for the treatment of: anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD); Immunoglobulin G4-related disease (IgG4-RD); anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive (Ab+) generalized myasthenia gravis (gMG).

UPLIZNA U.S. IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS 
UPLIZNA® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis.

WARNINGS AND PRECAUTIONS

Infusion Reactions: Infusion reactions, including anaphylaxis, can occur. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. Infusion reactions were observed in 9.3%, 7.4%, and 10.1% of patients treated with UPLIZNA during the randomized controlled periods (RCPs) of Study 1 in patients with NMOSD, Study 2 in patients with IgG4-RD, and Study 3 in patients with gMG, respectively. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions.
Administer pre-medication with a corticosteroid, an antihistamine, and an antipyretic. For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with B-cell depleting therapies, including UPLIZNA. The most common infections reported by UPLIZNA-treated patients in the NMOSD randomized and open-label clinical trial periods for NMOSD were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection, influenza, and pneumonia. In the gMG RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection and nasopharyngitis. Delay UPLIZNA administration in patients with an active infection until the infection is resolved.
  
Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects.Hepatitis B Virus (HBV) Reactivation: HBV reactivation has been observed with B-cell-depleting therapies, including UPLIZNA. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with B-cell depleting therapies. HBV reactivation was observed in a patient treated with UPLIZNA during the gMG clinical trial and in the postmarketing setting. Patients with active or chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment. Do not administer to patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for HBsAg and positive for HBcAb, or who are carriers of HBV (i.e., HBsAg+), consult liver disease experts before starting and during treatment.Progressive Multifocal Leukoencephalopathy (PML): Although no confirmed cases of PML were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.Tuberculosis 
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment.Vaccinations
Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion.
  
Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy 
In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B cells in these exposed infants may increase the risks from live or live-attenuated vaccines. Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.
   Reductions in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the levels of quantitative serum immunoglobulins during treatment with UPLIZNA, especially in patients with opportunistic or recurrent infections, and until B-cell repletion after discontinuation of therapy. Consider discontinuing UPLIZNA therapy if a patient with low immunoglobulin G or M develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
   Fetal Risk: Based on animal data, UPLIZNA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to UPLIZNA even after B-cell repletion. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell-depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving UPLIZNA and for at least 6 months after the last dose. ADVERSE REACTIONS

The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo): urinary tract infection and arthralgia in NMOSD; urinary tract infection and lymphopenia in IgG4-RD; headache and infusion-related reactions in gMG. Please see UPLIZNA® full Prescribing Information

TAVNEOS (avacopan) U.S. INDICATION
TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

TAVNEOS U.S. IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. In the postmarketing setting, vanishing bile duct syndrome (VBDS) as a consequence of liver injury, including cases with a fatal outcome, has been reported. These events occurred predominantly in Japan in patients aged 65 years and older, but VBDS may affect patients of any age or ethnicity who are receiving TAVNEOS. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. For patients of Japanese descent, consider more frequent laboratory testing: every 2 weeks after the start of therapy for the first 3 months, followed by laboratory testing every 4 weeks for the next 3 months of treatment, and as clinically indicated thereafter. If a patient receiving treatment with TAVNEOS presents with an elevation in alanine aminotransferase [ALT] or aspartate aminotransferase [AST] to >3 times the upper limit of normal, evaluate promptly and consider pausing treatment as clinically indicated. If AST or ALT is > 5 times the upper limit of normal (ULN), or ALT or AST > 3 times the ULN with total bilirubin > 2 times the ULN, or alkaline phosphatase ≥ 2 times the ULN, or if the patient has clinical symptoms such as jaundice or pruritus, discontinue TAVNEOS until TAVNEOS-induced liver injury is ruled out. Immediately and permanently discontinue TAVNEOS if VBDS is suspected. TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease. Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established. Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming. Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common. ADVERSE REACTIONS

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia. DRUG INTERACTIONS

Avoid co-administration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Consider dose reduction of CYP3A4 substrates when co-administering TAVNEOS.  Co‑administration of avacopan and 40 mg simvastatin increases the systemic exposure of simvastatin. While taking TAVNEOS, limit simvastatin dosage to 10 mg daily (or 20 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity). Consult the concomitant CYP3A4 substrate product information when considering administration of such products together with TAVNEOS. TAVNEOS is available as a 10 mg capsule.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.

More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, inflammatory conditions, rare diseases, heart disease and obesity and obesity-related conditions.

Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average® and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

CONTACT: Amgen, Thousand Oaks
Elissa Snook, 609-251-1407 (media)
Annik Allen, 917-288-9136 (media)
Casey Capparelli, 805-447-1746 (investors)

References

Stone J, et al. Oral Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #OP052. Stone J, et al. Poster Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #POS0440. Patel, N, et al. Poster Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #POS0867. Stone JH, Zen Y, Deshpande V. IgG4-related disease. N Engl J Med. 2012;366(6):539-551. Perugino CA, Stone JH. IgG4-related disease: an update on pathophysiology and implications for clinical care. Nat Rev Rheumatol. 2020;16(12):702-714. Patel, N, et al. Poster Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #POS0135. UPLIZNA (inebilizumab) Summary of Product Characteristics (SmPC). Available at Uplizna, INN-inebilizumab. Last accessed May 2026. TAVNEOS (avacopan) Summary of Product Characteristics (SmPC). Available at Tavneos, INN-avacopan. Last accessed May 2026. KRYSTEXXA (pegloticase) Summary of Product Characteristics (SmPC). Available at Krystexxa, INN-pegloticase. Last accessed May 2026. SOURCE Amgen

Ultragenyx (RARE) reported earnings 30 days ago. What's next for the stock?

Ultragenyx Pharmaceutical Inc. (RARE) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript

Posted by Defense World Staff on Apr 14th, 2026

Burney Co. bought a new stake in PTC Therapeutics, Inc. (NASDAQ:PTCT – Free Report) in the 4th quarter, according to its most recent 13F filing with the Securities & Exchange Commission. The institutional investor bought 26,569 shares of the biopharmaceutical company’s stock, valued at approximately $2,018,000.

Several other institutional investors and hedge funds have also made changes to their positions in the company. Smartleaf Asset Management LLC boosted its stake in shares of PTC Therapeutics by 101.3% in the third quarter. Smartleaf Asset Management LLC now owns 469 shares of the biopharmaceutical company’s stock valued at $28,000 after purchasing an additional 236 shares during the period. Optiver Holding B.V. boosted its stake in shares of PTC Therapeutics by 96.5% in the third quarter. Optiver Holding B.V. now owns 507 shares of the biopharmaceutical company’s stock valued at $31,000 after purchasing an additional 249 shares during the period. IFP Advisors Inc boosted its stake in shares of PTC Therapeutics by 68.1% in the third quarter. IFP Advisors Inc now owns 765 shares of the biopharmaceutical company’s stock valued at $47,000 after purchasing an additional 310 shares during the period. Arizona State Retirement System boosted its stake in shares of PTC Therapeutics by 2.0% in the third quarter. Arizona State Retirement System now owns 21,101 shares of the biopharmaceutical company’s stock valued at $1,295,000 after purchasing an additional 406 shares during the period. Finally, Mariner LLC boosted its stake in shares of PTC Therapeutics by 5.1% in the third quarter. Mariner LLC now owns 8,745 shares of the biopharmaceutical company’s stock valued at $537,000 after purchasing an additional 426 shares during the period.

Analyst Ratings Changes Several brokerages have recently weighed in on PTCT. Cantor Fitzgerald restated an “overweight” rating on shares of PTC Therapeutics in a research note on Friday, February 20th. Weiss Ratings restated a “hold (c)” rating on shares of PTC Therapeutics in a research note on Monday, December 29th. Truist Financial upgraded shares of PTC Therapeutics to a “strong-buy” rating in a research note on Wednesday, March 25th. Morgan Stanley upped their target price on shares of PTC Therapeutics from $90.00 to $92.00 and gave the company an “overweight” rating in a research note on Monday, February 23rd. Finally, Jefferies Financial Group cut shares of PTC Therapeutics from a “buy” rating to a “hold” rating and cut their price target for the company from $91.00 to $76.00 in a report on Monday, March 30th. One investment analyst has rated the stock with a Strong Buy rating, nine have assigned a Buy rating, five have given a Hold rating and one has given a Sell rating to the stock. Based on data from MarketBeat, the stock currently has an average rating of “Moderate Buy” and a consensus price target of $84.40.

Read Our Latest Stock Report on PTC Therapeutics

Insider Transactions at PTC Therapeutics In other PTC Therapeutics news, Director Stephanie Okey sold 15,167 shares of the stock in a transaction on Tuesday, March 10th. The shares were sold at an average price of $70.00, for a total transaction of $1,061,690.00. Following the sale, the director directly owned 8,000 shares of the company’s stock, valued at approximately $560,000. This represents a 65.47% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is available at the SEC website. Also, insider Neil Gregory Almstead sold 52,003 shares of the stock in a transaction on Wednesday, April 1st. The stock was sold at an average price of $69.04, for a total transaction of $3,590,287.12. Following the sale, the insider directly owned 60,137 shares in the company, valued at $4,151,858.48. This trade represents a 46.37% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders sold a total of 123,642 shares of company stock valued at $8,432,528 over the last ninety days. 5.50% of the stock is currently owned by corporate insiders.

PTC Therapeutics Price Performance PTCT opened at $70.42 on Tuesday. The stock has a market capitalization of $5.83 billion, a PE ratio of 9.10 and a beta of 0.55. The firm’s fifty day moving average price is $68.37 and its 200 day moving average price is $71.54. PTC Therapeutics, Inc. has a 12-month low of $35.95 and a 12-month high of $87.50.

PTC Therapeutics (NASDAQ:PTCT – Get Free Report) last posted its quarterly earnings results on Thursday, February 19th. The biopharmaceutical company reported ($1.67) earnings per share (EPS) for the quarter, missing the consensus estimate of ($0.21) by ($1.46). The company had revenue of $164.68 million during the quarter, compared to analyst estimates of $281.45 million. PTC Therapeutics had a net margin of 39.44% and a negative return on equity of 362.45%. The company’s revenue was down 22.7% on a year-over-year basis. During the same period in the prior year, the company earned ($0.85) earnings per share. On average, equities research analysts forecast that PTC Therapeutics, Inc. will post -4.52 earnings per share for the current fiscal year.

PTC Therapeutics Profile (Free Report)

PTC Therapeutics, Inc is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule and biologic therapies for the treatment of rare genetic disorders. Since its founding in 1998, PTC has dedicated its efforts to addressing high unmet medical needs by targeting underlying genetic causes of disease. The company’s research platform emphasizes mechanisms such as nonsense suppression and RNA modulation, enabling the development of novel treatments for conditions with limited therapeutic options.

Among PTC’s approved products is Translarna (ataluren), a first-in-class therapy designed to treat nonsense mutation Duchenne muscular dystrophy in select markets.

Further Reading Five stocks we like better than PTC Therapeutics

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, /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the company will host a webcast conference call to report its first quarter 2026 financial results and provide an update on the company's business and outlook on Thursday, May 7, 2026, at 4:30 p.m. ET.

To access the live webcast, please visit the "Events & Presentations" page within the Investors section of the PTC website. A replay of the webcast will be available on the PTC website for 30 days following the event. To participate via phone, please register in advance here to receive dial-in details.

ABOUT PTC THERAPEUTICS, INC.
PTC is a global biopharmaceutical company dedicated to the discovery, development and commercialization of clinically differentiated medicines for children and adults living with rare disorders. PTC is advancing a robust and diversified pipeline of transformative medicines as part of its mission to provide access to best-in-class treatments for patients with unmet medical needs. The company's strategy is to leverage its scientific expertise and global commercial infrastructure to optimize value for patients and other stakeholders. To learn more about PTC, please visit www.ptcbio.com and follow us on LinkedIn, X, Instagram and Facebook.

For more information, please contact:

Investors:
Ellen Cavaleri
+1 (615) 618-8228
[email protected]

Media:
Jeanine Clemente
+1 (908) 912-9406
[email protected]

SOURCE PTC Therapeutics, Inc.

, /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) will host a webcast conference call today, April 28 at 4:30 p.m. ET to share results from the 24-month interim analysis of the PIVOT-HD long-term extension study of votoplam. PTC's partner Novartis stated on its quarterly earnings call today that long-term extension data are supportive of the now-initiated Novartis Phase 3 INVEST-HD study and Novartis and PTC will assess potential best next steps for the program including further actions with FDA.

To access the live webcast, please visit the "Events & Presentations" page within the Investors section of the PTC website. A replay of the webcast will be available on the PTC website for 30 days following the event. To participate via phone, please register in advance here to receive dial-in details.

About PIVOT-HD
PIVOT-HD was designed as a 12-month placebo-controlled trial to assess pharmacodynamic effect and safety of votoplam at two dose levels--5mg and 10mg, relative to placebo. Initially, the study included only Stage 2 patients. A Stage 3 cohort of similar size was subsequently added to help identify the best study population for future studies. The primary endpoints of PIVOT-HD were total blood Huntingtin (HTT) lowering at 12 weeks and safety events. Secondary endpoints included 12-month blood HTT levels, and other blood-and central nervous system (CNS) biomarkers as well as changes in Composite Unified Huntington's Disease Rating Scale (cUHDRS).

Following 12 months, patients were eligible to enroll in a long-term extension study in which all subjects would receive votoplam. Those originally randomized to 5mg and 10mg would continue at that dose level; those initially randomized to placebo would be randomized 1:1 to 5mg or 10mg. All subjects and investigators remain blinded to initial treatment assignment.

About Votoplam
Votoplam (formerly PTC518) is a small molecule splicing modifier that acts via a unique mechanism to promote the inclusion of a novel pseudoexon containing a premature termination codon, thus triggering Huntingtin (HTT) mRNA degradation and subsequent reduction in HTT protein levels. Votoplam was discovered from PTC's validated splicing platform, following the successful discovery and development of Evrysdi® (risdiplam) for spinal muscular atrophy (SMA). Votoplam was partnered with Novartis in December 2024. Following the completion of the PIVOT-HD clinical trial, Novartis assumed responsibility for votoplam's development, manufacturing and commercialization.

About Huntington's Disease
Huntington's disease (HD) is a fatal, hereditary, genetic disorder of the central nervous system.1 It is caused by a defective gene. This gene produces a protein, called Huntingtin (HTT), which is involved in the functioning of the nerve cells in the brain (neurons). When the gene is defective, it produces an abnormal (or mutated) HTT protein that is toxic and causes neuron damage and neuron death.2 HD usually presents in people who are in their 30s or 40s. Symptoms can present earlier in life, and this is called Juvenile HD.2,3 There are also cases of infantile HD, when symptoms develop in children who are younger than 10 years old.2 While symptoms vary from person to person, the disease primarily affects the brain and results in abnormal movements, difficulties with speech, swallowing and walking, as well as a number of other symptoms including behavioral, cognitive and motor symptoms.4,5 While there are therapies approved for specific disease symptoms, currently, there is no cure for HD and there are no approved drugs that delay the onset or slow disease progression.

About PTC Therapeutics, Inc.
PTC is a global biopharmaceutical company dedicated to the discovery, development and commercialization of clinically differentiated medicines for children and adults living with rare disorders. PTC is advancing a robust and diversified pipeline of transformative medicines as part of its mission to provide access to best-in-class treatments for patients with unmet medical needs. The company's strategy is to leverage its scientific expertise and global commercial infrastructure to optimize value for patients and other stakeholders. To learn more about PTC, please visit www.ptcbio.com and follow us on LinkedIn, X, Instagram and Facebook.

For more information, please contact:

Investors:
Ellen Cavaleri
+1 (615) 618-8228
[email protected]

Media:
Jeanine Clemente
+1 (908) 912-9406
[email protected]

Forward-Looking Statement:
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historic fact, are forward-looking statements, including statements with respect to the future expectations, plans and prospects for PTC, PTC's strategy, including with respect to the expected timing of clinical trials and studies, availability of data, regulatory submissions and responses, and other matters, future operations, future financial position, future revenues, projected costs; and the objectives of management. Other forward-looking statements may be identified by the words, "guidance", "plan," "anticipate," "believe," "estimate," "expect," "intend," "may," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.

PTC's actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to: the outcome of pricing, coverage and reimbursement negotiations with third party payors for PTC's products or product candidates that PTC commercializes or may commercialize in the future; expectations with respect to PTC's license and collaboration agreement with Novartis Pharmaceuticals Corporation for votoplam for the treatment of Huntington's disease including its right to receive development, regulatory and sales milestones, profit sharing and royalty payments from Novartis, the design and expected timing of clinical trials and studies, the availability of data, and regulatory submissions and responses, including potential accelerated approval; significant business effects, including the effects of industry, market, economic, political or regulatory conditions; changes in tax and other laws, regulations, rates and policies; the eligible patient base and commercial potential of PTC's products and product candidates; PTC's scientific approach and general development progress; the sufficiency of PTC's cash resources and its ability to obtain adequate financing in the future for its foreseeable and unforeseeable operating expenses and capital expenditures; and the factors discussed in the "Risk Factors" section of PTC's most recent Annual Report on Form 10-K, as well as any updates to these risk factors filed from time to time in PTC's other filings with the SEC. You are urged to carefully consider all such factors.

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory or prove to be commercially successful. 

The forward-looking statements contained herein represent PTC's views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law. 

References:

World Health Organization, 2020. 8A01.10 Huntington disease. Available at: https://icd.who.int/browse10/2019/en#/G10. Accessed October 2021. Gatto EM, González Rojas N, Persi G, et al. Clin Parkinsonism Rel Disord 2020;3:100056. Tabrizi SJ, Flower MD, Ross CA, et al. Nat Rev Neurol 2020;16(10):529–546. Roos RAC. Orphanet J Rare Dis 2010; 5:40. Kirkwood SC, Su JL, Conneally P, et al. Arch Neurol 2001;58(2):273–278. SOURCE PTC Therapeutics, Inc.

According to a media report, the stock declined on concerns that the FDA may not grant accelerated approval based on the current data set.

PTC Therapeutics PIVOT-HD Update: What Drove PTCT Stock LowerThe interim analysis indicated a dose-dependent benefit on the Composite Unified Huntington’s Disease Rating Scale (cUHDRS) for Stage 2 participants, with a notable 52% slowing at the 10 mg dose, and 28% at the 5 mg dose.

The rare disorder-focused company said signals of favorable treatment effects relative to natural history were recorded across the cUHDRS subscales for the 10 mg cohort.

In addition, there were no treatment-related neurofilament light chain protein (NfL) increases, and mean NfL levels remained below baseline at 24 months for both high and low dose cohorts – in contrast to the reported natural history that NfL levels increase over time.

In Stage 3 participants, potential signals of slowing of progression were observed at 24 months.

The safety data at Month 24 for both dose levels and both stages were consistent with the previously established evidence of favorable safety. 

Additionally, Novartis AG (NYSE:NVS) initiated a global Phase 3 INVEST-HD study of votoplam, which is expected to further evaluate the drug’s efficacy.

The primary endpoint will be the change from baseline up to month 36 in the cUHDRS. The INVEST-HD study is sponsored and funded by Novartis.

PTCT Technical Analysis: Trend, Momentum And Key LevelsPTC Therapeutics is currently trading within a 52-week range that spans from $35.95 to $87.50, indicating it is positioned closer to the lower end of this range.

The stock is trading 8.9% below its 20-day simple moving average (SMA) and 10.9% below its 100-day SMA, suggesting a bearish short-term trend as it struggles to maintain upward momentum.

The relative strength index (RSI) is at 52.34, indicating a neutral momentum state, which suggests neither overbought nor oversold conditions currently prevail.

The moving average convergence divergence (MACD) is below the signal line, indicating bearish momentum, and the histogram is negative, suggesting that selling pressure may be building.

Key Resistance: $69.00 — A significant level where upward movements have previously stalled. Key Support: $61.50 — A critical level that could provide buying interest if tested. PTCT Stock Price Activity: PTC Therapeutics shares were down 9.08% at $63.88 at the time of publication on Wednesday, according to Benzinga Pro data.

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The market expects PTC Therapeutics (PTCT - Free Report) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.

The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on May 7. On the other hand, if they miss, the stock may move lower.

While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.

Zacks Consensus EstimateThis biopharmaceutical company is expected to post quarterly loss of $0.31 per share in its upcoming report, which represents a year-over-year change of -103.1%.

Revenues are expected to be $236.22 million, down 79.9% from the year-ago quarter.

Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 12.61% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.

Price, Consensus and EPS Surprise

Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for PTC Therapeutics?For PTC Therapeutics, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +14.09%.

On the other hand, the stock currently carries a Zacks Rank of #3.

So, this combination indicates that PTC Therapeutics will most likely beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that PTC Therapeutics would post a loss of$0.21 per share when it actually produced a loss of -$1.67, delivering a surprise of -695.24%.

Over the last four quarters, the company has beaten consensus EPS estimates three times.

Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

PTC Therapeutics appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

An Industry Player's Expected ResultsAnother stock from the Zacks Medical - Biomedical and Genetics industry, Arcutis Biotherapeutics, Inc. (ARQT - Free Report) , is soon expected to post loss of $0.02 per share for the quarter ended March 2026. This estimate indicates a year-over-year change of +90%. Revenues for the quarter are expected to be $99.15 million, up 50.6% from the year-ago quarter.

Over the last 30 days, the consensus EPS estimate for Arcutis Biotherapeutics has been revised 40% down to the current level. Nevertheless, the company now has an Earnings ESP of -20.00%, reflecting a lower Most Accurate Estimate.

When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Arcutis Biotherapeutics will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters.

Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.

The upcoming report from PTC Therapeutics (PTCT - Free Report) is expected to reveal quarterly loss of -$0.31 per share, indicating a decline of 103.1% compared to the year-ago period. Analysts forecast revenues of $236.22 million, representing a decline of 79.9% year over year.

The current level reflects an upward revision of 19.2% in the consensus EPS estimate for the quarter over the past 30 days. This demonstrates how the analysts covering the stock have collectively reappraised their initial projections over this period.

Prior to a company's earnings release, it is of utmost importance to factor in any revisions made to the earnings projections. These revisions serve as a critical gauge for predicting potential investor behaviors with respect to the stock. Empirical studies consistently reveal a strong link between trends in earnings estimate revisions and the short-term price performance of a stock.

While investors typically rely on consensus earnings and revenue estimates to gauge how the business may have fared during the quarter, examining analysts' projections for some of the company's key metrics often helps gain a deeper insight.

Given this perspective, it's time to examine the average forecasts of specific PTC Therapeutics metrics that are routinely monitored and predicted by Wall Street analysts.

It is projected by analysts that the 'Revenues- Net product revenue- Emflaza' will reach $23.56 million. The estimate suggests a change of -50.7% year over year.

The combined assessment of analysts suggests that 'Revenues- Net product revenue- Translarna' will likely reach $35.12 million. The estimate suggests a change of -59.3% year over year.

According to the collective judgment of analysts, 'Revenues- Royalty revenue' should come in at $49.33 million. The estimate indicates a change of +35.4% from the prior-year quarter.

Analysts expect 'Revenues- Net product revenue' to come in at $196.25 million. The estimate points to a change of +27.9% from the year-ago quarter.

View all Key Company Metrics for PTC Therapeutics here>>>

Over the past month, PTC Therapeutics shares have recorded returns of -6.5% versus the Zacks S&P 500 composite's +10.3% change. Based on its Zacks Rank #3 (Hold), PTCT will likely exhibit a performance that aligns with the overall market in the upcoming period. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> .

PTC Therapeutics (PTCT - Free Report) came out with a quarterly loss of $0.03 per share versus the Zacks Consensus Estimate of a loss of $0.45. This compares to earnings of $10.04 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +93.35%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.21 per share when it actually produced a loss of $1.67, delivering a surprise of -695.24%.

Over the last four quarters, the company has surpassed consensus EPS estimates three times.

PTC Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $272.55 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 16.63%. This compares to year-ago revenues of $1.18 billion. The company has topped consensus revenue estimates three times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

PTC Therapeutics shares have lost about 12.4% since the beginning of the year versus the S&P 500's gain of 7.6%.

What's Next for PTC Therapeutics?While PTC Therapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for PTC Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.31 on $254.33 million in revenues for the coming quarter and -$1.10 on $1.04 billion in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

Another stock from the same industry, Biorestorative Therapies, Inc. (BRTX - Free Report) , has yet to report results for the quarter ended March 2026.

This company is expected to post quarterly loss of $0.30 per share in its upcoming report, which represents a year-over-year change of +46.4%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Biorestorative Therapies, Inc.'s revenues are expected to be $0.05 million, up 66.7% from the year-ago quarter.

PTC Therapeutics, Inc. (PTCT) Q1 2026 Earnings Call Transcript